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    Chemistry

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    Also known as: Dextromethorphan hydrobromide, 125-69-9, Antussan, Demorphan, Dormethan, Metrorat
    Molecular Formula
    C18H26BrNO
    Molecular Weight
    352.3  g/mol
    InChI Key
    MISZALMBODQYFT-URVXVIKDSA-N
    FDA UNII
    Z0CG3115FG
    Dextromethorphan Hydrobromide
    Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
    1 2D Structure

    Dextromethorphan Hydrobromide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,9S,10S)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide
    2.1.2 InChI
    InChI=1S/C18H25NO.BrH/c1-19-10-9-18-8-4-3-5-15(18)17(19)11-13-6-7-14(20-2)12-16(13)18;/h6-7,12,15,17H,3-5,8-11H2,1-2H3;1H/t15-,17+,18+;/m1./s1
    2.1.3 InChI Key
    MISZALMBODQYFT-URVXVIKDSA-N
    2.1.4 Canonical SMILES
    CN1CCC23CCCCC2C1CC4=C3C=C(C=C4)OC.Br
    2.1.5 Isomeric SMILES
    CN1CC[C@@]23CCCC[C@@H]2[C@@H]1CC4=C3C=C(C=C4)OC.Br
    2.2 Other Identifiers
    2.2.1 UNII
    Z0CG3115FG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. D-methorphan

    2. Dextromethorphan

    3. Dextromethorphan Hydrobromide

    4. Dextromethorphan Hydrobromide, (+-)-isomer

    5. Dextromethorphan Hydrobromide, Monohydrate

    6. Dextromethorphan Hydrochloride

    7. Dextromethorphan, (+-)-isomer

    8. Hydrobromide, Dextromethorphan

    9. Hydrochloride, Dextromethorphan

    10. L-methorphan

    11. Levomethorphan

    12. Racemethorphan

    2.3.2 Depositor-Supplied Synonyms

    1. Dextromethorphan Hydrobromide

    2. 125-69-9

    3. Antussan

    4. Demorphan

    5. Dormethan

    6. Metrorat

    7. Medicon

    8. Tusilan

    9. Tussade

    10. D-methorphan Hydrobromide

    11. Romilar

    12. Methorate Hydrobromide

    13. Dextromethorphan Bromide

    14. Dextromethorphan (hydrobromide)

    15. Dextromethorphan Hydrobromide Anhydrous

    16. Ro 1-5470/5

    17. Dextromethorphan Hbr

    18. D-3-methoxy-n-methylmorphinan Hydrobromide

    19. Z0cg3115fg

    20. Benylin Dm

    21. (1s,9s,10s)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide

    22. Romilar Hydrobromide

    23. (9?,13?,14?)-3-methoxy-17-methylmorphinan Hydrobromide

    24. Dextroramin P

    25. Demorphine

    26. Dextrometorphan Hydrobromide

    27. Allfen-dm

    28. (1s,9s,10r)-4-methoxy-17-methyl-17-azatetracyclo[7.5.3.01,10.02,7]heptadeca-2(7),3,5-triene;hydrobromide

    29. Nsc-756723

    30. Demorphan Hydrobromide

    31. Einecs 204-750-1

    32. Dextromethorphan Polistirex

    33. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hydrobromide

    34. Unii-z0cg3115fg

    35. Canfodion

    36. Cosylan

    37. Dormetan

    38. Hihustan M.

    39. Ro 1-5470

    40. Dxm Hbr

    41. 9-alpha,13-alpha,14-alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide

    42. Schembl121924

    43. Morphinan, 3-methoxy-n-methyl-, Hydrobromide, (+)-

    44. Chembl1201004

    45. Dtxsid60872346

    46. Bcp06595

    47. Hy-b0620

    48. Dextromethorphan Hbr Anhydrous

    49. Mfcd00269810

    50. Akos022186323

    51. Ccg-212567

    52. Nsc 756723

    53. Dextromethorphan Hydrobromide [mi]

    54. Dextromethorphan Hydrobromide [who-dd]

    55. Q27294835

    56. (9alpha,13alpha,14alpha)-3-methoxy-17-methylmorphinan Hbr

    57. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hbr

    58. Morphinan, 3-methoxy-17-methyl-, (9alpha,13alpha,14alpha)-, Hydrobromide

    59. 3-methoxy-17-methyl-9.alpha.,13.alpha.,14.alpha.-morphinan Hydrobromide

    60. 9alpha,13alpha,14alpha-morphinan, 3-methoxy-17-methyl-, Hydrobromide (8ci)

    61. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hbr

    62. Morphinan, 3-methoxy-17-methyl-, (9.alpha.,13.alpha.,14.alpha.)-, Hydrobromide

    63. Morphinan, 3-methoxy-17-methyl-, Hydrobromide (1:1),(9.alpha.,13.alpha.,14.alpha.)-

    64. (4bs,8as,9s)-3-methoxy-11-methyl-6,7,8,8a,9,10-hexahydro-5h-9,4b-(epiminoethano)phenanthrene Hydrobromide

    65. 1887136-04-0

    2.4 Create Date
    2005-06-08
    3 Chemical and Physical Properties
    Molecular Weight 352.3 g/mol
    Molecular Formula C18H26BrNO
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count1
    Exact Mass351.11978 g/mol
    Monoisotopic Mass351.11978 g/mol
    Topological Polar Surface Area12.5 Ų
    Heavy Atom Count21
    Formal Charge0
    Complexity370
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDelsym
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyReckitt Benckiser

    2 of 4  
    Drug NameDextromethorphan polistirex
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyTris Pharma

    3 of 4  
    Drug NameDelsym
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyReckitt Benckiser

    4 of 4  
    Drug NameDextromethorphan polistirex
    Active IngredientDextromethorphan polistirex
    Dosage FormSuspension, extended release
    RouteOral
    Strengtheq 30mg hbr/5ml
    Market StatusOver the Counter
    CompanyTris Pharma

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Excitatory Amino Acid Antagonists

    Drugs that bind to but do not activate excitatory amino acid receptors, thereby blocking the actions of agonists. (See all compounds classified as Excitatory Amino Acid Antagonists.)

    Antitussive Agents

    Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Sigma-1 Receptor Agonists [MoA]; Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]; Uncompetitive NMDA Receptor Antagonists [MoA]; Sigma-1 Agonist [EPC]

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"292.2","totalValueFC":"590.2","currency":"USD","unitRateINR":"24795","date":"09-Oct-2024","totalValueINR":"49590","totalValueInUsd":"590.2","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6024485","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"DEXTROMETHORPHAN HBR IP","address":"202, SAI PLAZA, SANT NAGAR","city":"NEW DELHI","supplier":"M\/S.DIVIS LABORATORIES LIMITD-DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PRETTY PETALS PRIVATE ","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"61","totalValueFC":"30810","currency":"USD","unitRateINR":"5200","date":"18-Nov-2024","totalValueINR":"2600000","totalValueInUsd":"30810","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6726134","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE, CHOUTUPPAL(M) YADADRI BHUVANAGIRI DISTRICT SDNF India","customerAddress":"202, SAI PLAZA, SANT NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"DEXTROMETHORPHAN HBR USP2024","address":"GODREJ COLISUEM,SOMAIYA HOSPITAL RD","city":"SION-E .MUMBAI MAHARASHTRA","supplier":"M\/S.DIVIS LABORATORIES LIMITED DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"OLIVE HEALTHCARE","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"117.2","totalValueFC":"2962.5","currency":"USD","unitRateINR":"10000","date":"25-Nov-2024","totalValueINR":"250000","totalValueInUsd":"2962.5","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29339990","bill_no":"6860752","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE, CHOUTUPPAL(M) YADADRI- BHUVANAGIRI (DT),HYDERABAD SDNF India","customerAddress":"GODREJ COLISUEM,SOMAIYA HOSPITAL RD"}]
    25-Jan-2021
    31-Dec-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    (KGS)    		 Average Price
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    Drugs in Development

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    Mucinex Children's Launches Mighty Chews

    Details:

    Mighty Chews consisting, Dextromethorphan HBr, is the first and only over-the-counter medicated children's soft chew for cough relief.


    Lead Product(s): Dextromethorphan Hydrobromide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Mighty Chews

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2024

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    01

    Reckitt Benckiser

    United Kingdom
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    Not Confirmed

    Reckitt Benckiser

    United Kingdom
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    Not Confirmed
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    Lead Product(s) : Dextromethorphan Hydrobromide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Mucinex Children's Launches Mighty Chews

    Details : Mighty Chews consisting, Dextromethorphan HBr, is the first and only over-the-counter medicated children's soft chew for cough relief.

    Product Name : Mighty Chews

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 30, 2024

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    ANI Pharmaceuticals Launches Oral Solution For Cough And Allergy Relief

    Details:

    Promethazine HCl and Dextromethorphan Hydrobromide-Generic is an approved oral solution, which is indicated for the patients suffering from cough.


    Lead Product(s): Promethazine Hydrochloride,Dextromethorphan Hydrobromide

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Promethazine HCl-Dextromethorphan HBr-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 13, 2024

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    02

    ANI Pharmaceuticals Inc

    U.S.A
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    Not Confirmed

    ANI Pharmaceuticals Inc

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Promethazine Hydrochloride,Dextromethorphan Hydrobromide

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ANI Pharmaceuticals Launches Oral Solution For Cough And Allergy Relief

    Details : Promethazine HCl and Dextromethorphan Hydrobromide-Generic is an approved oral solution, which is indicated for the patients suffering from cough.

    Product Name : Promethazine HCl-Dextromethorphan HBr-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 13, 2024

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    Axsome Therapeutics Presents New Data from the EVOLVE Open-Label Trial Demonstrating Effects of AUVELITY® on Cognitive and Physical Functioning in Pa...

    Details:

    AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg).


    Lead Product(s): Dextromethorphan Hydrobromide,Bupropion Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Auvelity

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 07, 2022

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    03

    Axsome Therapeutics

    U.S.A
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    Not Confirmed

    Axsome Therapeutics

    U.S.A
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    Lead Product(s) : Dextromethorphan Hydrobromide,Bupropion Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Axsome Therapeutics Presents New Data from the EVOLVE Open-Label Trial Demonstrating Effects of AU...

    Details : AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg).

    Product Name : Auvelity

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    December 07, 2022

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    Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disord...

    Details:

    AUVELITY (dextromethorphan hydrobromide) is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week.


    Lead Product(s): Dextromethorphan Hydrobromide,Bupropion Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Auvelity

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 19, 2022

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    04

    Axsome Therapeutics

    U.S.A
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    Not Confirmed

    Axsome Therapeutics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Dextromethorphan Hydrobromide,Bupropion Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor A...

    Details : AUVELITY (dextromethorphan hydrobromide) is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week.

    Product Name : Auvelity

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    August 19, 2022

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    Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Healthcare Products

    Details:

    This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, Primatene Tablets® and FiberCon®.


    Lead Product(s): Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Dimetapp

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Foundation Consumer Healthcare

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement July 16, 2020

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    Lead Product(s) : Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Foundation Consumer Healthcare

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Foundation Consumer Healthcare to Add Seven Over-the-Counter Brands to Expanding Portfolio of Heal...

    Details : This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, P...

    Product Name : Dimetapp

    Product Type : Small molecule

    Upfront Cash : Undisclosed

    July 16, 2020

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    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 30MG HYDROBROMIDE/5ML

    USFDA APPLICATION NUMBER - 18658

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG;600MG

    USFDA APPLICATION NUMBER - 21620

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;1.2GM

    USFDA APPLICATION NUMBER - 21620

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    DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5...DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

    USFDA APPLICATION NUMBER - 88811

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    ABOUT THIS PAGE

    Looking for 125-69-9 / Dextromethorphan Hydrobromide API manufacturers, exporters & distributors?

    Dextromethorphan Hydrobromide manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Dextromethorphan Hydrobromide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextromethorphan Hydrobromide manufacturer or Dextromethorphan Hydrobromide supplier.

    PharmaCompass also assists you with knowing the Dextromethorphan Hydrobromide API Price utilized in the formulation of products. Dextromethorphan Hydrobromide API Price is not always fixed or binding as the Dextromethorphan Hydrobromide Price is obtained through a variety of data sources. The Dextromethorphan Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Dextromethorphan Hydrobromide

    Synonyms

    125-69-9, Antussan, Demorphan, Dormethan, Metrorat, Medicon

    Cas Number

    125-69-9

    Unique Ingredient Identifier (UNII)

    Z0CG3115FG

    About Dextromethorphan Hydrobromide

    Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

    Dextromethorphan Hydrobromide Manufacturers

    A Dextromethorphan Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextromethorphan Hydrobromide, including repackagers and relabelers. The FDA regulates Dextromethorphan Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextromethorphan Hydrobromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Dextromethorphan Hydrobromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Dextromethorphan Hydrobromide Suppliers

    A Dextromethorphan Hydrobromide supplier is an individual or a company that provides Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) or Dextromethorphan Hydrobromide finished formulations upon request. The Dextromethorphan Hydrobromide suppliers may include Dextromethorphan Hydrobromide API manufacturers, exporters, distributors and traders.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Dextromethorphan Hydrobromide USDMF

    A Dextromethorphan Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Dextromethorphan Hydrobromide DMFs exist exist since differing nations have different regulations, such as Dextromethorphan Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Dextromethorphan Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Dextromethorphan Hydrobromide USDMF includes data on Dextromethorphan Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextromethorphan Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with USDMF on PharmaCompass.

    Dextromethorphan Hydrobromide JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Dextromethorphan Hydrobromide Drug Master File in Japan (Dextromethorphan Hydrobromide JDMF) empowers Dextromethorphan Hydrobromide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Dextromethorphan Hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of Dextromethorphan Hydrobromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with JDMF on PharmaCompass.

    Dextromethorphan Hydrobromide KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Dextromethorphan Hydrobromide Drug Master File in Korea (Dextromethorphan Hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dextromethorphan Hydrobromide. The MFDS reviews the Dextromethorphan Hydrobromide KDMF as part of the drug registration process and uses the information provided in the Dextromethorphan Hydrobromide KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Dextromethorphan Hydrobromide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dextromethorphan Hydrobromide API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Dextromethorphan Hydrobromide suppliers with KDMF on PharmaCompass.

    Dextromethorphan Hydrobromide CEP

    A Dextromethorphan Hydrobromide CEP of the European Pharmacopoeia monograph is often referred to as a Dextromethorphan Hydrobromide Certificate of Suitability (COS). The purpose of a Dextromethorphan Hydrobromide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dextromethorphan Hydrobromide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dextromethorphan Hydrobromide to their clients by showing that a Dextromethorphan Hydrobromide CEP has been issued for it. The manufacturer submits a Dextromethorphan Hydrobromide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dextromethorphan Hydrobromide CEP holder for the record. Additionally, the data presented in the Dextromethorphan Hydrobromide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dextromethorphan Hydrobromide DMF.

    A Dextromethorphan Hydrobromide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dextromethorphan Hydrobromide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with CEP (COS) on PharmaCompass.

    Dextromethorphan Hydrobromide WC

    A Dextromethorphan Hydrobromide written confirmation (Dextromethorphan Hydrobromide WC) is an official document issued by a regulatory agency to a Dextromethorphan Hydrobromide manufacturer, verifying that the manufacturing facility of a Dextromethorphan Hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dextromethorphan Hydrobromide APIs or Dextromethorphan Hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a Dextromethorphan Hydrobromide WC (written confirmation) as part of the regulatory process.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with Written Confirmation (WC) on PharmaCompass.

    Dextromethorphan Hydrobromide NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Dextromethorphan Hydrobromide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Dextromethorphan Hydrobromide API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Dextromethorphan Hydrobromide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Dextromethorphan Hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dextromethorphan Hydrobromide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Dextromethorphan Hydrobromide suppliers with NDC on PharmaCompass.

    Dextromethorphan Hydrobromide GMP

    Dextromethorphan Hydrobromide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Dextromethorphan Hydrobromide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dextromethorphan Hydrobromide GMP manufacturer or Dextromethorphan Hydrobromide GMP API supplier for your needs.

    Dextromethorphan Hydrobromide CoA

    A Dextromethorphan Hydrobromide CoA (Certificate of Analysis) is a formal document that attests to Dextromethorphan Hydrobromide's compliance with Dextromethorphan Hydrobromide specifications and serves as a tool for batch-level quality control.

    Dextromethorphan Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Dextromethorphan Hydrobromide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Dextromethorphan Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextromethorphan Hydrobromide EP), Dextromethorphan Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextromethorphan Hydrobromide USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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